The undersigned organizations,
representing cancer patients, physicians, and researchers, recommend modifications
of the draft Model Guidelines for 2007 and also urge an extension of the
comment period to permit a more meaningful response to these important
guidelines.

Comment Period

We appreciate the
decision by United States Pharmacopeia (USP) to extend the comment period
on the draft Model Guidelines until Friday, January 6, 2006. However,
because the draft Model Guidelines did not become available for public
review until the second week of December 2005, the comment period is only
slightly longer than three weeks. This period of time hardly provides
an adequate opportunity to develop and submit comments on such an important
document. In addition, the comment period coincides with two of the most
widely observed national holidays, further undermining the public's meaningful
opportunity to comment.

Although we are submitting
brief comments on several key issues, we urge an extension of the comment
period until the end of January 2006 to permit thoughtful consideration
of the draft by interested parties. We appreciate that prescription drug
plan sponsors require significant advance notice of revised guidelines
to adjust their formularies accordingly, but extending the comment period
one month should not hamper their ability to respond to revisions of the
Model Guidelines by January 2007.

Therapeutic Category
of Antineoplastics

The treatment of antineoplastics
in the draft Model Guidelines for 2007 represents an improvement over
the treatment of these agents in the 2006 guidance. The draft document
adds a number of pharmacological classes in the antineoplastic category,
to clarify that there may be clinical distinctions or to establish that
Part B or Part D coverage may be applicable, depending on setting and
route of administration. The draft also amends the 2006 document to include
formulary key drug types (FKDTs), a modification that will provide important
guidance to drug plan sponsors.

We recommend that
the pharmacologic class of sex hormones/modifiers, included in the draft
in the therapeutic category of hormonal agents/suppressants, be included
instead as a pharmacological class in the therapeutic category of antineoplastics.
Despite their unique mechanism of action, these agents fundamentally function
to inhibit or prevent the growth of cancer cells. For breast and prostate
cancer patients, these agents are critical elements of anticancer therapy.
Inclusion of these agents as antineoplastic agents would be a more accurate
clinical classification and would be consistent with their usage in cancer
care.

Antiemetics

The therapeutic category
of antiemetics includes no pharmacologic classes but does list two formulary
key drug types: 5-HT3 antagonists and non-5-HT3 antagonists. Control of
nausea and vomiting is critical to maintaining the quality of life for
patients in active treatment and also to ensuring that side effects do
not disrupt treatment. Because cancer patients may have variable responses
to different categories of antiemetics, the greatest possible degree of
flexibility in management of nausea and vomiting is necessary.

We commend USP for
distinguishing the 5-HT3 antagonists from the older classes of drugs that
were used for management of chemotherapy-induced nausea. However, the
draft guidelines do not include a key drug type, the NK1 antagonist, a
new class of drugs that has a different mechanism of action from the older
drugs or 5-HT3 antagonists and is important for control of nausea and
vomiting in response to moderately and highly emetogenic chemotherapy.
We recommend, for the purpose of appropriate clinical distinctions and
for clarification of Part B or Part D coverage, that three pharmacologic
classes be included in the antiemetic category: 5-HT3 antagonists, NK1
antagonists, and other antiemetics (non-5-HT3 antagonists and non-NK1
antagonists).

Smoking Cessation
Drugs

The current draft
does not identify a category or class of drugs that would include prescription
smoking cessation agents. In its March 2005 decision memorandum providing
Medicare coverage for smoking and tobacco use cessation counseling, the
Centers for Medicare & Medicaid Services (CMS) cited as support for
its coverage decision the 2000 Public Health Service guidelines on smoking
cessation that recommend that smokers utilize counseling and behavioral
therapies as well as pharmacotherapies to improve their chances of permanent
cessation of smoking. In subsequent materials describing Medicare smoking
cessation benefits, the agency has detailed Medicare coverage of counseling
services along with coverage of smoking cessation drugs prescribed by
a physician, which it describes as being covered under Part D beginning
in January 2006.

We strongly urge the
revision of the guidelines to include a therapeutic category of "antismoking
agents." This would ensure that Medicare beneficiaries have access
to the most effective
smoking cessation program, which may combine counseling with pharmacotherapy.
This would be consistent with the intent of Congress and CMS to provide
Medicare beneficiaries the best available tools to quit smoking.

Process for Updating
the Model Guidelines

We urge USP to develop
a process for regular and timely updates of its model classification system.
Such updates will guarantee the proper classification of novel therapies.
We are optimistic that several new cancer therapies will be approved before
the next annual review of the guidelines, and the USP guidelines should
be regularly updated to reflect such treatment advances. Without such
a process, patients will be left to rely on timely review of new therapies
by plans' pharmacy and therapeutics committees or to depend on their ability
to utilize the exceptions process to obtain access to a new drug not included
on a formulary. For many cancer patients, reliance on these strategies
for obtaining access to drugs may result in harmful delays in care.